HIGH

Sedecal Recalled 6 Mobile X-ray Systems for Cleaning Not Water-Resistant Issue (2025)

Sedecal recalled 6 mobile X-ray systems distributed in CA, IL and NJ after warning consignees the equipment is not water-resistant. Cleaning must follow the manual to avoid improper cleaning. Hospitals should stop using the devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
June 10, 2025
Hazard Level
HIGH
Brand
SEDECAL
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
3 states
At-Risk Groups
GENERAL

Hazard Information

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

Sedecal SM-40HF-B-D-C and the 40KW70CDEMO.005 are mobile X-ray systems used in clinical imaging within hospitals and clinics.

Why This Is Dangerous

The devices are not water-resistant and must be cleaned only as described in the manual. Improper cleaning could damage the unit or lead to operational issues.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals must halt use of the affected units to prevent potential damage or malfunction affecting patient imaging services.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers SM-40HF-B-D-C and 40KW70CDEMO.005.
  2. Verify serial numbers G38652, G37633, G36042, G37641, 608A, G36681.
  3. Confirm UDI/DI 08436046001510.
  4. Cross-check against distribution list CA, IL, NJ.

Where to find product info

Recall details available at the FDA enforcement page linked in the notice. Serial numbers and UDI/DI appear on the unit label and in the device documentation.

What timeline to expect

No remediation timeline provided. Recalls for medical imaging equipment vary by facility and manufacturer.

If the manufacturer is unresponsive

  • Document outreach efforts to Sedecal SA and your healthcare provider.
  • Escalate to the hospital’s risk management team if the manufacturer is unresponsive.

How to prevent similar issues

  • Ensure cleaning procedures strictly follow the manual for any medical imaging device.
  • Train staff on the specific cleaning requirements and water exposure limits.
  • Verify device labels and documentation before any maintenance or cleaning.

Documentation advice

Keep a copy of the recall notice, serial numbers, model numbers and all correspondence with Sedecal SA and healthcare providers for records.

Product Details

Model numbers SM-40HF-B-D-C and 40KW70CDEMO.005. Distribution US: CA, IL, NJ. Sold unknown. Price unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 6 units recalled
  • Model SM-40HF-B-D-C; 40KW70CDEMO.005
  • UDI/DI 08436046001510
  • Serials: G38652, G37633, G36042, G37641, 608A, G36681
  • Distribution: CA, IL, NJ (US)
  • Recall date: 2025-06-10

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
SM-40HF-B-D-C
40KW70CDEMO.005
UDI/DI 08436046001510
G38652
G37633
+4 more
Affected States
CA, IL, NJ
Report Date
October 29, 2025
Recall Status
ACTIVE

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